Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction, 87787-87788 [2023-27859]
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Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Jeremy
Walenty has been convicted of a felony
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that the offense should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. Walenty is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
drug by, with the assistance of, or at the
direction of Mr. Walenty is a prohibited
act.
approval of the applications be
withdrawn.
[FR Doc. 2023–27855 Filed 12–18–23; 8:45 am]
BILLING CODE 4164–01–P
Approval is withdrawn as of
January 18, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5431]
Hospira, Inc., et al.; Withdrawal of
Approval of Eight Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of eight
abbreviated new drug applications
(ANDAs) from multiple applicants. The
applicants notified the Agency in
writing that the drug products were no
longer marketed and requested that the
SUMMARY:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived the
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 063081 ........
Hospira, Inc., 275 North Field Dr., Building H1–3S, Lake
Forest, IL 60045.
ANDA 080629 ........
Tobramycin Sulfate, Injectable, Equivalent to (EQ) 1.2 milligrams (mg) base/milliliters (mL), EQ 1.6 mg base/mL, EQ
80 mg base/100 mL.
Tobramycin Sulfate, Injection, EQ 10 mg base/mL ...............
Fentanyl Citrate, Troche/Lozenges, EQ 0.2 mg base, EQ
0.4 mg base, EQ 0.6 mg base, EQ 0.8 mg base, EQ 1.2
mg base, EQ 1.6 mg base.
Promethazine Hydrochloride (HCl), Injectable, 50 mg/mL ....
ANDA 091170 ........
Zoledronic Acid, Injectable, EQ 4 mg base/5 mL ..................
ANDA 201846 ........
Azelastine HCl, Metered Spray, 0.2055 mg/spray .................
ANDA 207698 ........
Nevirapine Extended-Release Tablets, 400 mg ....................
ANDA 208616 ........
Nevirapine Extended-Release Tablets, 100 mg ....................
ANDA 063112 ........
ANDA 078907 ........
lotter on DSK11XQN23PROD with NOTICES1
Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
87787
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 18,
2024. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
listed in the table without an approved
new drug application or ANDA violates
sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in the table that are in
inventory on January 18, 2024 may
continue to be dispensed until the
VerDate Sep<11>2014
17:33 Dec 18, 2023
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Do.
SpecGx LLC, 385 Marshall Ave., Webster Groves, MO
63119.
Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Parkway, Building A, Parsippany, NJ 07054.
Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite
201, Berlin, CT 06037.
Apotex Corp, U.S. Agent for Apotex Inc., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326.
Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo
Pharma Limited, 279 Princeton-Hightstown Rd., East
Windsor, NJ 08520.
Do.
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[Docket No. FDA–2009–N–0026]
[FR Doc. 2023–27853 Filed 12–18–23; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Food and Drug Administration
Apothecon, et al.; Withdrawal of
Approval of 103 New Drug
Applications and 35 Abbreviated New
Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on February 11, 2009. The
SUMMARY:
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87788
Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices
document announced the withdrawal of
approval of 103 new drug applications
and 35 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of March 13,
2009. The document erroneously
included ANDA 75–108. The correct
ANDA is ANDA 76–108 for Amiodarone
hydrochloride (HCl) injection, 50
milligrams (mg)/milliliter (mL), held by
Hospira, Inc., 275 North Field Dr., Lake
Forest, IL 60045–5046. This document
corrects that error.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
In the
Federal Register of February 11, 2009
(74 FR 6896), appearing on page 6900 in
FR Doc. E9–2901, the following
correction is made:
On page 6900, in the table, in the first
column, the Application No. for the
entry for Amiodarone HCL Injection, 50
mg/mL held by Hospira Inc., 275 North
Field Dr., Lake Forest, IL 60045–5046 is
corrected to ANDA 76–108.
SUPPLEMENTARY INFORMATION:
Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27859 Filed 12–18–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0955–0019]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
SUMMARY:
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 20, 2024.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0955–0019 and
project title for reference, to Sherrette A.
Funn, email: Sherrette.Funn@hhs.gov,
PRA@HHS.GOV or call (202) 264–0041
the Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: National
Survey of Health Information Exchange
Organizations (HIO).
Type of Collection: Revision of a
previously approved collection.
OMB No.: 0955–0019.
Abstract: Under the Department of
Health and Human Services, Office of
National Coordinator for Health
Information and Technology, Electronic
health information exchange (HIE) was
one of three goals specified by Congress
in the 2009 Health Information
Technology for Economic and Clinical
Health (HITECH) Act to ensure that the
$30 billion federal investment in
certified electronic health records
(EHRs) resulted in higher-quality, lowercost care. Subsequent legislation and
regulations have continued to prioritize
the sharing of data electronically across
EHRs and other health information
systems. Health information exchange
organizations (HIOs) play a pivotal role
facilitating health information exchange
across disparate providers, labs,
pharmacies, public health departments,
and others. This information collection
request will gather data from HIOs
across the nation through the
administration of a survey of HIOs to
generate the most current national
statistics and associated actionable
insights to inform policy efforts. The
timely collection of national data from
our survey will assess current
capabilities of HIOs to support effective
electronic information sharing within
the U.S. healthcare system.
Since prior to HITECH there has been
ongoing assessment of trends in the
capabilities of HIOs to support clinical
exchange through nationwide surveys of
HIOs. These prior surveys and studies
have collected data on organizational
structure, financial viability, geographic
coverage, scope of services, scope of
participants, perceptions of information
blocking, support for public health
exchange, and participation in national
networks and the Technical Exchange
Framework and Common Agreement
(TEFCA). Continuing the ongoing data
collection will be useful to construct a
current and comprehensive picture of
HIOs’ role in facilitating exchange and
ensuring rapid access to important
health care data and information when
it matters most, including vital data to
address public health emergencies.
The survey will collect data on HIO
capabilities to support electronic health
information exchange, their maturity,
and challenges they face. There are five
key areas that require assessment: (1)
adoption of technical standards; (2)
perceptions related to information
blocking; (3) HIE coordination at the
federal level; (4) public health data
exchange; and (5) organizational
demographics, including technical
capabilities offered by HIOs and the
challenges they face in supporting
electronic health information exchange.
This is a 3-year request for OMB
approval.
ANNUALIZED BURDEN HOUR TABLE
lotter on DSK11XQN23PROD with NOTICES1
Forms
(if necessary)
Total ............................
VerDate Sep<11>2014
Respondents
(if necessary)
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Total burden
hours
U.S. based public and private HIOs ...............
100
1
45/60
75
.........................................................................
........................
1
........................
75
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]]>Agencies
[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87787-87788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27859]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0026]
Apothecon, et al.; Withdrawal of Approval of 103 New Drug
Applications and 35 Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on February 11, 2009. The
[[Page 87788]]
document announced the withdrawal of approval of 103 new drug
applications and 35 abbreviated new drug applications (ANDAs) from
multiple applicants, withdrawn as of March 13, 2009. The document
erroneously included ANDA 75-108. The correct ANDA is ANDA 76-108 for
Amiodarone hydrochloride (HCl) injection, 50 milligrams (mg)/milliliter
(mL), held by Hospira, Inc., 275 North Field Dr., Lake Forest, IL
60045-5046. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of February 11, 2009
(74 FR 6896), appearing on page 6900 in FR Doc. E9-2901, the following
correction is made:
On page 6900, in the table, in the first column, the Application
No. for the entry for Amiodarone HCL Injection, 50 mg/mL held by
Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045-5046 is
corrected to ANDA 76-108.
Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27859 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P
